TABLE 2. Clinical outcomes abstracted from outcome forms of patients with Monkeypox virus infection who received tecovirimat (Tpoxx) under the Food and Drug Administration–regulated Expanded Access Investigational New Drug protocol (N = 369) — United States, May–August 2022.

Outcome (no. unknown or missing)	No. (%)
Hospitalized (38)
Yes*	23 (6.9)
Intensive care unit*	2 (0.6)
No	308 (93.1)
Outcome† (52)
Recovered without sequelae	189 (59.6)
Recovered with sequelae	41 (12.9)
Not yet recovered	87 (27.4)
Days to subjective improvement§ (114)
Median, days (IQR)	3.0 (2–4)
Adverse event¶ (29)
Yes	12 (3.5)
No	328 (96.5)
Median no. of days to follow up after treatment initiation (IQR)**
During treatment: assessment A (day 1–7)	6 (4–7)
During treatment: assessment B (day 8–14)	10 (8–13)
Posttreatment: assessment C	21 (20–23)
Assessment A (day 1–7) (156)	213 (57.7)
New lesions (22)
Yes	25 (13.1)
No	166 (86.9)
All lesions crusted and healed with new layer of skin (59)
Yes	49 (31.8)
No	105 (68.2)
Assessment B (day 8–14) (187)	182 (49.3)
New lesions (19)
Yes	22 (13.5)
No	141 (86.5)
All lesions crusted and healed with new layer of skin (25)
Yes		78 (49.7)
No		79 (50.3)
Assessment C (posttreatment) (225)		144 (39.0)
New lesions (7)
Yes		3 (2.2)
No		134 (97.8)
All lesions crusted and healed with new layer of skin (11)
Yes		119 (89.5)
No		14 (10.5)

* Hospitalized at any time after symptom onset. Among 23 patients hospitalized, two patients were admitted to the intensive care unit.

^†At latest follow-up visit, which might have been during treatment or posttreatment. Recovery status was defined by clinical judgment of the treating provider.

^§ Time to first observed (including patient-reported) improvement.

^¶ All adverse events included headache (three), nausea (two), visual disturbance (two), weakness (two), vomiting (one), asymptomatic elevated liver function tests (one), hospitalization for psychiatric reasons (one), rash (one), hives (one), numbness (one), fatigue (one), and dizziness (one).

** Nonmissing data.